Milestones

Established for over a decade, we committed to becoming a global leader in innovative diagnosis and precision medicine focused in women’s health.

2025

Completed C1 round financing, led by Jinhua Venture Capital with Yuanbio Venture Capital continue to increase investment.

2024

Launched CercaTest® RED, the first non-invasive, home-test preeclampsia detection Point-of-Care test in the world.

Collaborate with global IVD giant Sysmex to promote MammaTyper® in over 20 countries in Europe, Africa and other regions.

2023

Launched FOXCARD® Fudan, the sub-typing for triple negative breast cancer.

Received NMPA class III registration approval for our Human Breast Cancer Molecular Subtyping Quantitative Detection Kit. MammaTyper® launched to market.

2022

Received NMPA class III registration approval for our qPCR kit for mutation detection in the MTHFR gene (C677T).

Obtained the CE mark for several IVD products.

Launched maxBRCA ™, a proprietary NGS testing service for comprehensive analysis the BRCA1/2 genes featuring the capabilities of identifying large rearrangements.

2021

Obtained nearly 100 million RMB in financing

EndoPredict® became recommended in the Breast Cancer Diagnosis and Treatment Guideline from the China Anti-Cancer Association (CACA)

Established the German subsidiary (Cerca).

2020

Received NMPA class II registration approval for first-in-kind device for point-of-care diagnosis of pre-eclampsia (CapCord) in pregnant women.

Collaboration agreement signed with PerkinElmer for marketing the pre-eclampsia POC diagnostic device in China

Designated as the International Cooperation Base for In Vitro Diagnostics in Zhejiang ProvinceR&D Center recognized as “High-Tech Enterprise R&D Center”

2018-2019

RDS projects were selected as key research and development projects in Zhejiang Province in 2019.

Guanz Laboratory Center won the title of “Zhejiang Provincial International Science and Technology Cooperation Base”.

Shuwen Biotech was recognized as a National High-Tech Enterprise.

Completed A+ round of financing with a leading pharm company.

Established Hangzhou branch as a core R&D center.

2014-2017

The Xuancheng, Anhui Province branch was established as a production base for IVD kits in the field of maternal fetal medicine.

Completed financing from a major investment fund in Shenzhen.

The Shuwen Guanz Diagnostic Laboratories received CAP accreditation from the College of American Pathologists, a first of such accreditation in a private lab in Zhejiang Province.

Shuwen Biotech received ISO13485 certification.

MammaTyper® received breakthrough product designation from the NMPA.

Completed A round financing.

Signed collaboration agreement with BioNTech to co-develop MammaTyper®.

Central lab received license for conducting PCR and genetic testing.

Shuwen Guanz Diagnostic Laboratories Co. Ltd. was established and received operating license from health authorities to offer diagnostic services.

Shuwen Health Co. Ltd. was established as a marketing arm for central lab LDT services.

Completed seed financing.

2010-2013

Shuwen Biotech Co. Ltd. was founded in China by Jay Z. Zhang, former Senior VP of Myriad Genetics.

Signed exclusive patent license agreement with Max-Planck Institute and Cologne University for novel theranostic biomarkers.

Exclusive patent license agreement with Yale University for novel biomarkers in maternal fetal medicine.